Kala Pharmaceuticals, Inc., a leading developer of innovative ophthalmic products based on the company’s proprietary Mucus Penetrating Particle (MPP) platform , announced the initiation of two clinical trials with its nanotechnology based loteprednoletabonate MPP (LE MPP) programme, KPI 121 Kala has initiated dosing in its Phase 3 trial ( KPI 121 C 001 ) to evaluate the safety and efficacy of LE MPP in managing inflammation and pain associated with cataract surgery . In addition, Kala has initiated a Phase 2 trial ( KPI 121 C 002 ) with KPI 121 to investigate the safety and efficacy of low dose LE MPP in patients with dry eye disease .
“ We are pleased to advance the clinical development of KPI 121 , the first product candidate leveraging Kala’s proprietary MPP delivery platform , ” said Guillaume Pfefer, Ph.D., president and chief executive officer of Kala. “ Kala is a pioneer in the application of nanotechnology to ophthalmology . Our goal is to leverage the power of our Mucus Penetrating P article technology to develop new and better treatments for multiple ocular diseases . We believe that nanotechnology has the potential to transform the treatment of eye disease s in much the same way it has already transformed other therapeutic areas. ”
Kala’s proprietary MPP nano technology platform allows therapeutic agents to pass through the mucus layer of the tear film , facilitating penetration into deeper tissues of the eye, including the cornea, aqueous humor and retina.
“ Ocular pain and inflammation is a significant issue among patients living with dry eye disease, as well as those who have undergone cataract surgery; rapid and efficient treatment for this inflammation is paramount ,” said Terry Kim, M.D., Professor of Ophthalmology at Duke University. “Kala’s pre clinical data demonstrate that the MPP technology can enhance the pharmacokinetic properties of existing therapeutics to improve penetration to various tissues of the eye. I look forward to continuing to work with Kala on these trials, and am excited about the potential for the MPP technology to improve the treatment of ocular disease.”
Phase 3 Clinical Trial to Evaluate LE MPP Following Cataract Surgery (KPI 121 C 001)
In a Phase 3, double masked, randomised, controlled trial, Kala will investigate the efficacy and safety of 1 per cent LE MPP dosed two times daily and 0.25 per cent LE MPP dosed four times daily as compared to placebo in subjects who have undergone cataract surgery and who require treatment of postoperative anterior ocular inflammation . Kala aims to enroll approximately 375 patients in 25 centres in the US.
In preclinical studies, LE MPP demonstrated a superior pharmacokinetics profile in target tissues compared to currently marketed loteprednoletabonate products. In head to head preclinical studies, LE MPP delivered significantly greater levels of drug to the aqueous humor, as well as the cornea, conjunctiva and retina than either Lotemax Suspension or Lotemax Gel, with similar dosing regimens.
Phase 2 Clinical Trial to Evaluate LE MPP in Dry Eye Disease (KPI 121 C 002 )
In a Phase 2, double masked, randomised, controlled study of LE MPP, Kala will investigate the safety and efficacy of 0 .25 per cent LE MPP compared to vehicle dosed four times daily in subjects who have a documented clinical diagnosis of dry eye disease. Kala aims to enroll approximately 150 patients in up to one per cent centres in the US.
Later in 2014, Kala will initiate two additional clinical trials with LE -¬- MPP . The first is a Phase 2 t rial with 0.25 per cent LE MPP versus vehicle dosed four times daily in inflammatory meibomian gland disease ( posterior blepharitis) . The second is an exploratory trial with one per cent LE MPP and 0.25 per cent LE MPP dosed four times daily in subjects diagnosed with diabetic macular edema or retinal vein occlusion to evaluate the ability to treat retinal diseases via topical administration. The company continues to advance its novel, small molecule receptor tyrosine kinase inhibitor (RTKi) MPP programme towards a development candidate selection .